Spotlight sessions at the upcoming Lyophilization USA Conference
Lyophilization is one of the most time consuming and expensive unit operations. There are many issues within lyopilization which need addressing, and improved drying technologies are needed for current and future products.
Featuring an exceptional line-up of keynote speakers from industry leading organisations, SMi’s 4th Lyophilization USA conference arrives at the perfect time to discuss novel techniques and advances; regulatory and freeze-drying challenges; finally, alternatives to conventional methods.
Agenda highlights will include a spotlight on novel PAT and QbD principles, scale up and technology transfer, bulk lyophilization, and assessing phase separation in lyophilized protein formulation.
Comparing and contrasting two methods of controlled nucleation for use in lyophilization: A live viral vaccine (LVV) perspective
- Evaluation of two methods of controlled nucleation: pressurization / depressurization technology and “ice-fog” technology
- Can controlled nucleation impart consistency whilst maintaining vaccine potency?
- Impact on cycle time, consistency and moisture levels
Morrisa Jones, Senior Scientist, Vaccine Drug Product Development, Merck & Co., Inc.
Freeze dryer characterization and application to drug product development and scale up
- Characterization of bench, pilot and industrial scale freeze dryers
- Product characterization & measurement of Rp
- Application of models to the development of a lyophilization cycle
- Scale up
- PAT applications to development and scale up
Timothy McCoy, Associate Director, Pharmaceutical Development, Biologics Research and Development, Sanofi
Challenges of lyophilized product development
- Formulation challenges
– Excipients selection
– Dosage forms: solution, suspension, & oral melt
– Route of administration: iv, im and oral
– Solvents: aqueous and non-aqueous
– API: biologics & small molecules
- Process challenges
- Device selections
Yanming Zu, Director, Research and Development, Abon Pharmaceuticals
For media enquiries, contact Jinna Sidhu on +44 (0) 20 7827 0688 or email@example.com
Conference: November 15 – 16, 2018
Workshops: November 14, 2018
Venue: Renaissance Woodbridge Hotel, New Jersey, USA
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